title: Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.
abstract: OBJECTIVE
  The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual.
  
  
  METHODS
  EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials.
  
  
  RESULTS
  Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure.
  
  
  CONCLUSIONS
  Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.
authors.affiliation: Nancy N. and J.C. Lewis Cancer & Research Pavilion, St Joseph's/Candler Hospital, Savannah, GA, USA.
authors.forename: Howard A
authors.initials: HA
authors.lastname: Zaren
authors.forename: Suresh
authors.initials: S
authors.lastname: Nair
authors.forename: Ronald S
authors.initials: RS
authors.lastname: Go
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Enos
authors.forename: Keith S
authors.initials: KS
authors.lastname: Lanier
authors.forename: Michael A
authors.initials: MA
authors.lastname: Thompson
authors.forename: Jinxiu
authors.initials: J
authors.lastname: Zhao
authors.forename: Deborah L
authors.initials: DL
authors.lastname: Fleming
authors.forename: John C
authors.initials: JC
authors.lastname: Leighton
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Gribbin
authors.forename: Donna M
authors.initials: DM
authors.lastname: Bryant
authors.forename: Angela
authors.initials: A
authors.lastname: Carrigan
authors.forename: Jennifer C
authors.initials: JC
authors.lastname: Corpening
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Csapo
authors.forename: Eileen P
authors.initials: EP
authors.lastname: Dimond
authors.forename: Christie
authors.initials: C
authors.lastname: Ellison
authors.forename: Maria M
authors.initials: MM
authors.lastname: Gonzalez
authors.forename: Jodi L
authors.initials: JL
authors.lastname: Harr
authors.forename: Kathy
authors.initials: K
authors.lastname: Wilkinson
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Denicoff
mesh_terms: D002173:Cancer Care Facilities / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic; D003153:Community Health Services / Q000706:statistics & numerical data*; D006801:Humans; D015337:Multicenter Studies as Topic; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000188:drug therapy; D015397:Program Evaluation; D014481:United States